Appropriate Medical Governance at companies is increasing in need, scope, and importance in the industry. The patient is at the core of this. The public, regulators, providers, and markets expect that principles of good medical science and ethical standards are consistently applied globally across the product lifecycle from development to post-marketing surveillance and promotional practices all the way through to product withdrawal.
Medical issues must be identified internally and proactively managed with stakeholders, including regulators, providers, prescribers, and the general public because information travels fast these days – across markets as well as within the public domain over channels like social media.
In order to successfully operate in this environment, companies must be able to navigate through evolving regulatory requirements and have in place:
- Empowered multi-functional, governance bodies with clear remits
- Policies that are well-understood and enforceable
- Compliant processes with well-defined escalation paths
- Integrated technologies providing accurate, near real-time data from a multitude of sources
Medical Governance must also be risk-based and supported at the Chief Medical Officer (CMO) level. In addition, it is also vital that medical standards are truly global and applied to both partners and local markets, presenting its own set of challenges as companies continually explore sourcing options and expand into new markets.
We are in an era requiring R&D models that not only need internal multi-functional alignment beginning from the earliest phases of development, but also ongoing external engagement with stakeholders who are keen to understand the value of a product based on its benefit-risk profile relative to what is already on the market as well as what will be on the market.
At Navitas, we have worked with companies to ensure medical decisions are consistent throughout the business enabling them to approach external stakeholders with a single voice. From companies that are only in late stage development to those that have marketed products spread across divisions and multiple therapeutic areas, we can help you through this journey and make this change happen.
cmonet is the network for Chief Medical Officers to share insights, exchange ideas, and offer peer support. The founding group of CMOs, led by Mike Devoy of Bayer HealthCare, initiated the community given emergent expectations of the role from regulators and the diversity in scope and positioning of the role in the industry.
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